第4章 開發的平台

第5章 市場預測

全球市場

美國

加拿大

歐洲主要5個國家

日本

第6章 推動市場要素與阻礙

推動市場要素

障礙

第7章 許可證與共同開發交易

許可證交易

共同開發交易

第8章 附錄

圖表

目錄

Product Code: GBIHC321MR

GBI Research, has released the pharma report, "Hepatitis C Therapeutics in Major Developed Markets to 2019 - Outstanding Recent Approvals and Late-Stage Pipeline to Transform Clinical and Commercial Landscape". The current Hepatitis C treatment landscape consists of a combination of pegylated interferon, ribavirin and, in patients infected with genotype 1 hepatitis C, one of two direct-acting antiviral agents (DAAs). Products with these mechanisms of action have performed strongly in the commercial setting, with the market leader Incivek (a DAA) having reached blockbuster sales.

However, these products are very poorly tolerated and only moderately efficacious. The approval of the DAA Sovaldi in December 2013 changed this, with a complete viral clearance being achieved in close to 100% of patients and a much improved adverse event profile compared to previous standards of therapy. In patients with genotype 2 and 3 hepatitis C, Sovaldi does not need to be administered with pegylated interferon. A number of products in the late-stage pipeline, which promise to be even more efficacious and safe are anticipated to enter the market over the forecast period, including several interferon-free therapies for genotype 1-infected patients. As a result of this, as well as an overall increase in the treated population, GBI Research believes the global market has the potential to grow to a value of $18.6 billion by 2019, more than tripling the 2012 market value of $5.8 billion.

Scope

A brief introduction to hepatitis C, including the disease's pathogenesis, risk factors and diagnosis, and detailed analyses of disease epidemiology and treatment algorithms.

In-depth analysis of the major antiviral drugs used in the treatment of hepatitis C, including analyses of their safety, efficacy, treatment patterns and strengths/weaknesses. Includes a heat map that compares marketed drugs in terms of safety and efficacy.

A comprehensive review of the pipeline for hepatitis C therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market during the forecast period. The pipeline is analyzed by phase distribution, molecule type and molecular target.

In-depth clinical trial enrolment, trial duration and program failure rate analyses for each molecule type and mechanism of action. Additionally, clinical trial endpoints and certain selection criteria are analyzed in great depth. This section also includes an additional heat map regarding pipeline products, and a direct cross-analysis against currently marketed products.

Multi-scenario forecast data of the market to 2019, which takes into account the effects of the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets: US, Canada, Japan, Germany, UK, France, Italy and Spain.

Discussion of the drivers and barriers for market growth.

Analysis of licensing and co-development deals occurring in the hepatitis C market.

Reasons to buy

Understand the different types of hepatitis C therapies and how treatment varies by genotype.

Understand the treatment algorithms and guidelines related to hepatitis C, how they are anticipated to change during the forecast period and where opportunities and unmet needs lie.

Understand the vast scope of the pipeline, including which molecule types and mechanisms of action are most prominent.

Observe the shift in clinical trial endpoints with each clinical Phase, and use this data to potentially influence any future developmental programs. Additionally, understand the trends in enrolment by patient genotype.

Assess the potential clinical and commercial impact of current late-stage pipeline molecules and the points of opportunity which remain to be capitalized upon.

Abstract

Due to a large untreated patient pool and the recent approval of new treatments, the hepatitis C market will more than treble from $5.7 billion in 2012 to $18.6 billion by 2019, at an impressive Compound Annual Growth Rate (CAGR) of 18.5%, forecasts business intelligence provider GBI Research.

The company's new report* states that the hepatitis C market will receive this major boost with the 2013 approval of Sovaldi, which has the potential to transform the treatment algorithm for hepatitis C. Due to the clinical potential of the drug, Sovaldi will be very expensive, reaching a cost of $86,000 annually and setting a high price benchmark for future drugs.

Dominic Trewartha, Analyst for GBI Research, says: "Sovaldi boasts excellent tolerability and a Sustained Virologic Response rate approaching 100%, without specificity to any genotype 1. In genotypes 2 and 3, Sovaldi is administered with ribavirin alone, alleviating the need for Pegasys or Pegintron and therefore reducing the rate of adverse events associated with these two therapies. As a result, many patients who have previously deferred treatment are expected to re-enter the market and use Sovaldi."

Additional drugs, such as Olysio, which was also approved in 2013, and daclatasvir are anticipated to compete with Sovaldi, although they are not proven to be as effective and can only be used in genotype 1 infections.

According to GBI Research, Sovaldi-ledipasvir and ABT-450 triple therapy will further advance the hepatitis C market and displace older drugs from 2015 onwards. This is due to the fact that these therapies can be used without peginterferon and have demonstrated 100% efficacy in genotype 1, with strong tolerability and low dosing.

"The late-stage pipeline for hepatitis C is exceptionally promising, and we expect new products to completely transform the clinical and commercial landscape during the forecast period," Trewartha concludes.

*Hepatitis C Therapeutics in Major Developed Markets to 2019 - Outstanding Recent Approvals and Late-Stage Pipeline to Transform Clinical and Commercial Landscape

This report provides in-depth analysis of the major antiviral drugs used in the treatment of hepatitis C, including analyses of their safety, efficacy, treatment patterns and strengths/weaknesses. It also gives a market forecast between 2012 and 2019.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.